2,2'-[(4-methylphenyl)imino]bisethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16. Section 1500.41

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(4-methylphenyl)imino]bisethanol

EC Number:

221-359-1

EC Name:

2,2'-[(4-methylphenyl)imino]bisethanol

Cas Number:

3077-12-1

Molecular formula:

C11H17NO2

IUPAC Name:

2,2'-[(4-methylphenyl)imino]diethanol

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Germany
- Weight at study initiation: 2.4 kg
- Housing: Animals were individually housed.
- Diet: Mümmel z (ssniff, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 -14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

left flank of each animal was intact; right flank of each animal was abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

24 h
Reading time points: approximately 30 min after removal of the test substance (24-h reading time point) and 48 (72-h reading time point) and 72 h after start of the experiment

Observation period:

8 d

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: The treated skin was covered with a gauze, held in place with a PVC foil and Leukoflex® adhesive plaster. The whole body of the animal was wrapped with elastic Eloflex® during the exposure period.

SCORING SYSTEM:
- Method of calculation: Draize Scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

individual score of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

edema score

Basis:

animal: #2, #3 and #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal: #5 and #6

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

The dermal application of the test substance did not result in erythema in any of the animals tested at any observation time point. Thus, the erythema score for all animals was 0 over 24, 48 and 72 h, respectively. 1/6 animals showed a slight edema 24 h (grade 2) and 72 h (grade 1) after the test substance application, respectively, which was fully reversible within 8 days, resulting in an edema score of 1.66 over 24, 48 and 72 h, respectively. 2/6 animals showed slight edema (grade 1) at the 24-h reading time point. At the 72-h reading time point the dermal effect was completely reversible, resulting in an edema score of 0.66 for both animals over 24, 48 and 72 h, respectively. In 3/6 animals the dermal application of the test substance did not result in edema in at any observation time point.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	0	2	0	0	0	0	0	0	0	1	0	1
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	0	1	0	0	0	0	0	0	0	0	0	0

Table 2. Calculation of mean scores

	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	0,00	1,67	0,00	0,00	0,00	0,00	0,00	0,00	0	0,67	0,00	0,67

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

Based on the results of this study, no skin irritating properties were determined in rabbits after dermal application of the test substance.